Early Versus Delayed Routine HIV Testing in Connecticut Jails (SWAB)

October 16, 2014 updated by: Yale University
The objective of this non-randomized, controlled, trial is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary outcome: proportion of individuals in each assigned group that agree to be swabbed for HIV testing and are able to consent to the study.

The prevalence of HIV infection in the United States is four times greater in correctional settings compared to the general population. Because prisons and jails house a population facing a disproportionate share of the burden of HIV infection, these facilities serve as important sites for the testing and treatment of HIV. The Center for Disease Control and Prevention's recent recommendations to implement routine opt-out HIV testing in all healthcare settings presents an important challenge and opportunity to correctional institutions. By effectively implementing routine opt-out testing, correctional facilities can expand HIV testing to one of society's most at-risk populations. Subsequently, testing can lead to appropriate access to counseling and treatment both within the correctional setting and upon release into the community.

Although jails interact with a larger number of individuals at risk for HIV infection than do prisons, they also pose unique logistical and health-related constraints in several important ways that impact HIV testing strategies. Jail populations experience short periods of incarceration and high rates of turnover with many-fold greater admissions and discharges. Jails also house individuals with higher rates of acute intoxication from psychoactive drugs, uncontrolled mental illness, and suicidal behavior. The suicide rate in jails is three times that in state prisons; nearly a quarter of these suicides take place within the first 48 hours of admission. Furthermore, the individuals who enter jails have higher recent risk behaviors for HIV than those in prisons.

Given these considerations, a major challenge to implementing routine opt-out HIV testing in jails is choosing the optimal time to conduct testing. The timing of delivering non-emergent, traumatically emotional health information (such as a preliminary positive result in an asymptomatic patient) must be carefully considered. Recently incarcerated inmates might be too intoxicated or psychologically distressed to demonstrate capacity to consent to or opt out of routine testing, and may be unprepared to consider and respond to the consequences of a preliminary positive HIV test result. Likewise, the challenge with postponing testing is that many individuals experience very short stays in jail, with approximately one-third leaving within 48 hours, followed by further attrition daily for the first week and may lose the opportunity for getting life-saving information in a timely manner.

Therefore, the objective of this study is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.

Study Type

Interventional

Enrollment (Actual)

621

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • New Haven Community Correctional Center
      • Niantic, Connecticut, United States, 06357
        • York Correctional Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All newly incarcerated inmates will be eligible for this study.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Immediate
Individuals assigned to be approached for routine HIV testing immediately upon admission to the jail.
Other: routine HIV testing
Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.
Other: Following Day
Individuals assigned to be approached for routine HIV testing the day following admission to the jail.
Other: routine HIV testing
Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.
Other: Delayed
Individuals assigned to be approached for routine HIV testing several days following admission to the jail.
Other: routine HIV testing
Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.
Time Frame: Immediately, the following evening, and 7 days post-entry
Immediately, the following evening, and 7 days post-entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Frederick L Altice, MD, Yale University AIDS Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 18, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0705002664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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